Cesarean SectionNCT04074005
Incidence and Factors Involving Cesarean Delivery After Epidural Analgesia for Labor
An observational study of Cesarean Section and Epidural; Anesthesia, run by Mahidol University at 1 site in Thailand.
Trial summary
The rate of cesarean delivery after epidural analgesia for labor has not been reported in our institute. The aim of this study is to elucidate incidence of cesarean delivery in parturient whom received epidural analgesia. Besides, factors associated with the rate of cesarean delivery were studied. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section, Epidural; Anesthesia
- How many people
- 188 participants
- Where
- 1 siteThailand
- Study dates
- 1 Mar 2020to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women whom admitted in labor ward for delivering baby as well as accept to receive epidural analgesia for labor
Who may be able to join
- Age>,= 18 years
- Accept epidural analgesia for labor
- ASA classification I-II
Who cannot join
- Unable to communicate Thai
Trial locations and contacts
1 site in 1 country.
About this study
The rate of cesarean delivery after epidural analgesia for labor has not been reported in our institute. The aim of this study is to elucidate incidence of cesarean delivery in parturient whom received epidural analgesia. Besides, factors associated with the rate of cesarean delivery were studied.
Read the detailed description
Epidural analgesia with local anesthetic and opioid is the efficiently good method to relieve labor pain comparing with intravenous opioid analgesic. Many literatures reported effects epidural analgesia for labor eg. prolonging the duration of second stage of labor, increasing the rate of instrumental delivery: vacuum extraction and forceps assisting labor. Some papers revealed the increasing in the rate of cesarean delivery. The main reason is assume to be a failure to progress labor after epidural analgesia. However, the recent report from Cochrane database systematic review showed no relation of epidural analgesia for labor and the increasing in the rate of cesarean delivery. Various factors that may involve in the increasing in the rate of cesarean delivery including the dilatation of cervix at the time of insertion of epidural catheter, nulliparous, size of the fetus or motor weakness after receiving epidural medication.
The rate of cesarean delivery after epidural analgesia for labor has not been reported in our institute. The aim of this study is to elucidate incidence of cesarean delivery in parturient whom received epidural analgesia. Besides, factors associated with the rate of cesarean delivery were studied.
- Conditions
- Cesarean Section, Epidural; Anesthesia
- Keywords
- Epidural analgesia, Labor pain, Cesarean section rate
- Medical subject headings
- Labor Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cesarean delivery after epidural analgesia for labor
Rate of cesarean delivery after patients receive epidural analgesia for relieve labor pain
Measured: From epidural catheter insertion to delivery
Secondary outcomes (6)
Factors affecting rate of cesarean delivery after epidural analgesia for labor
cervical dilatation before insertion epidural catheter (cm.)
Measured: at the time epidural catheter insertion
Efficacy of epidural analgesia for labor
pain score (verbal rating scale pain score)
Measured: before and after epidural catheter insertion
Side effects of epidural analgesia for labor: nausea and vomiting
nausea and vomiting (rating by patients: 0= no symptom, 1= nausea 2= vomiting)
Measured: From epidural catheter insertion to delivery
Side effects of epidural analgesia for labor: pruritus
pruritus (0=no, 1=yes)
Measured: From epidural catheter insertion to delivery
Side effects of epidural analgesia for labor: numbness of legs
numbness of legs (0=no, 1=yes)
Measured: From epidural catheter insertion to delivery
Side effects of epidural analgesia for labor: motor weakness
Rate motor weakness by Bromage score
Measured: From epidural catheter insertion to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start1 Mar 2020
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patchareya Nivatpumin, M.D., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074005
- Sponsor's protocol ID
- 020/2562 (EC4)
- Status last verified
- Dec 2025
- First submitted
- 4 May 2019
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nivatpumin P, Triyasunant N, Visalyaputra S, Lertbunnaphong T, Saenyasiri N. Incidence and associated factors of cesarean delivery following epidural analgesia for labor: A prospective cohort study at a Thai university hospital. Midwifery. 2025 Sep;148:104501. doi: 10.1016/j.midw.2025.104501. Epub 2025 Jun 24.
PubMed 40609139
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Factors Involving Cesarean Delivery After Epidural Analgesia for Labor
- ClinicalTrials.gov ID
- NCT04074005
- Acronym / sponsor ID
- 020/2562 (EC4)
- Conditions
- Cesarean Section, Epidural; Anesthesia
- Keywords
- Epidural analgesia, Labor pain, Cesarean section rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 29 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rate of cesarean delivery after epidural analgesia for labor has not been reported in our institute. The aim of this study is to elucidate incidence of cesarean delivery in parturient whom received epidural analgesia. Besides, factors associated with the rate of cesarean delivery were studied.
Detailed description
Epidural analgesia with local anesthetic and opioid is the efficiently good method to relieve labor pain comparing with intravenous opioid analgesic. Many literatures reported effects epidural analgesia for labor eg. prolonging the duration of second stage of labor, increasing the rate of instrumental delivery: vacuum extraction and forceps assisting labor. Some papers revealed the increasing in the rate of cesarean delivery. The main reason is assume to be a failure to progress labor after epidural analgesia. However, the recent report from Cochrane database systematic review showed no relation of epidural analgesia for labor and the increasing in the rate of cesarean delivery. Various factors that may involve in the increasing in the rate of cesarean delivery including the dilatation of cervix at the time of insertion of epidural catheter, nulliparous, size of the fetus or motor weakness after receiving epidural medication.
The rate of cesarean delivery after epidural analgesia for labor has not been reported in our institute. The aim of this study is to elucidate incidence of cesarean delivery in parturient whom received epidural analgesia. Besides, factors associated with the rate of cesarean delivery were studied.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women whom admitted in labor ward for delivering baby as well as accept to receive epidural analgesia for labor
Key inclusion criteria (3 listed)
- Age>,= 18 years
- Accept epidural analgesia for labor
- ASA classification I-II
Key exclusion criteria (1 listed)
- Unable to communicate Thai
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of cesarean delivery after epidural analgesia for labor
Time frame: From epidural catheter insertion to delivery
Rate of cesarean delivery after patients receive epidural analgesia for relieve labor pain
6 secondary outcomes
Factors affecting rate of cesarean delivery after epidural analgesia for labor
Time frame: at the time epidural catheter insertion
Efficacy of epidural analgesia for labor
Time frame: before and after epidural catheter insertion
Side effects of epidural analgesia for labor: nausea and vomiting
Time frame: From epidural catheter insertion to delivery
Side effects of epidural analgesia for labor: pruritus
Time frame: From epidural catheter insertion to delivery
Side effects of epidural analgesia for labor: numbness of legs
Time frame: From epidural catheter insertion to delivery
Side effects of epidural analgesia for labor: motor weakness
Time frame: From epidural catheter insertion to delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 40609139Nivatpumin P, Triyasunant N, Visalyaputra S, Lertbunnaphong T, Saenyasiri N. Incidence and associated factors of cesarean delivery following epidural analgesia for labor: A prospective cohort study at a Thai university hospital. Midwifery. 2025 Sep;148:104501. doi: 10.1016/j.midw.2025.104501. Epub 2025 Jun 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patchareya Nivatpumin, M.D. principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section and Epidural; Anesthesia, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cesarean delivery after epidural analgesia for labor (time frame: From epidural catheter insertion to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04074005, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.